Generic Drugs - Availability and Patent Status

Please note - Generic drug information listed on the Drugs.com website should be used as a guideline only. Always consult your doctor or healthcare specialist before changing any medicines.

Note: Brand name prescription medications are approved by the U.S. Food and Drug Administration and may be covered by legal patents that delay the availability of lower cost generic substitutes. Fraudulent online pharmacies may attempt to sell illegal "generic" versions of these brand name medications. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

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More about Generic Drugs

A generic drug is equivalent to it's brand name counterpart, but is usually much less expensive. A generic drug must have the same active ingredients, route of administration, dosage form, strength, and indications as the original brand product. Generic drugs are approved by the U.S. Food and Drug Administration, and are deemed to be as safe and effective as the brand name product.

Generics cannot be sold until after the drug patent expires on the original brand name product. For example, generic fluoxetine could not be sold until the patent had expired on the brand name equivalent Prozac. A drug manufacturer applies for a patent to protect their drug from being copied and sold by another company and losing profits.

Patents typically expire 20 years from the date of filing. During this period of patent protection, only the original manufacturer can research, develop and sell the brand name drug. When the patent expires, other manufacturers can submit an abbreviated new drug application (ANDA) to the FDA for approval to market the generic version.

Generic drugs have lower research costs and increased market competition and those substantial savings are passed on to the patient. However, generic drugs still must meet strict FDA requirements with respect to quality, performance, labeling, manufacturing, and bioequivalence. By law, generic drugs must have the same active ingredients as the brand name product, and they can be expected to have the same effect when used in place of a brand name drug.